[HTML][HTML] Question-based review for pharmaceutical development: An enhanced quality approach

A Simões, F Veiga, C Vitorino - European Journal of Pharmaceutics and …, 2024 - Elsevier
Over the last years, the pharmaceutical industry has faced real challenges regarding quality
assurance. In this context, the establishment of more holistic approaches to the …

Drilling into “Quality by Design” approach for analytical methods

L Chiarentin, C Gonçalves, C Augusto… - Critical Reviews in …, 2024 - Taylor & Francis
The need for consistency in analytical method development reinforces the dependence of
pharmaceutical product development and manufacturing on robust analytical data. The …

A stepwise framework for the systematic development of lipid nanoparticles

J Basso, M Mendes, T Cova, J Sousa, A Pais… - Biomolecules, 2022 - mdpi.com
A properly designed nanosystem aims to deliver an optimized concentration of the active
pharmaceutical ingredient (API) at the site of action, resulting in a therapeutic response with …

Analytical method development supported by DoE-DS approach for enantioseparation of (S, S)-and (R, R)-moxifloxacin

M Rašević, A Malenović, A Protić, M Zečević - Journal of Pharmaceutical …, 2023 - Elsevier
In this paper, method for enantiomeric purity testing of fourth-generation fluoroquinolone,
moxifloxacin hydrochloride, was developed and validated. Exceptional enantioselectivity for …

[HTML][HTML] Particle size by design: Standardizing measurements for complex topical drug product assessment

L Chiarentin, V Moura, F Major, J Catita… - Colloids and Surfaces A …, 2025 - Elsevier
The physicochemical and biopharmaceutical properties of drug substances and dosage
forms can be significantly influenced by particle size. However, the diversity of equivalent …

Validation of symmetrical two-dose parallel line assay model for nystatin potency determination in pharmaceutical product

M Eissa, ER R Rashed, DE Eissa - Journal of Advanced Pharmacy …, 2021 - journals.ekb.eg
Objectives: The microbiological antibiotic assay is an important quality control test for the
determination of the potency of the antimicrobials whose activity cannot be estimated by the …

A brief review on application of design of experiment for the analysis of pharmaceuticals using HPLC

SD Patil, SS Chalikwar - Annales Pharmaceutiques Françaises, 2023 - Elsevier
Summary The quality pioneer Dr. Joseph M. Juran first proposed the idea of quality by
design. According to him, pharmaceutical quality by design is an organised approach to …

[PDF][PDF] Design of Experiment Approach for Method Development and Validation of Bilastine in Pure and Pharmaceutical Dosage form using RP-UFLC.

LS REDDY, RN RAO… - Oriental Journal of …, 2023 - pdfs.semanticscholar.org
Background: Bilastine is a H1 receptor antagonist, used in the treatment of allergic urticaria,
seasonal rhinitis, etc. Few journals have reported the analytical related work on bilastine …

Stability-Indicating High-Performance Thin-Layer Chromatography Method Development and Validation for Topiroxostat in Bulk and Tablet Dosage Forms Using a …

SS Gaikwad, PV Dhakne, AS Bansode… - Journal of Analytical …, 2024 - Springer
A new, simple, rapid, accurate, and precise high-performance thin-layer chromatography
(HPTLC) method has been developed for the estimation of topiroxostat in bulk and tablet …

[PDF][PDF] A Stepwise Framework for the Systematic Development of Lipid Nanoparticles. Biomolecules 2022, 12, 223

J Basso, M Mendes, T Cova, J Sousa, A Pais… - 2022 - academia.edu
A properly designed nanosystem aims to deliver an optimized concentration of the active
pharmaceutical ingredient (API) at the site of action, resulting in a therapeutic response with …